Hypotension During SurgeryNCT06247384
The Hypotension Prediction Index in Major Abdominal Surgery
A study testing Hypotension Prediction Index Hemodynamic Monitoring in people with Hypotension During Surgery, run by Jakub Szrama at 1 site in Poland.
Trial summary
The goal of this randomized clinical trial is to compare different types of advanced hemodynamic monitoring in patients undergoing major abdominal surgery. Participants undergoing major abdominal surgery will receive anesthesia with two different types of hemodynamic monitoring - group A will receive arterial pressure… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypotension During Surgery
- What is being tested?
- Hypotension Prediction Index Hemodynamic Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients qualified for elective major abdominal surgery, defined as an expected duration of more than two hours, an estimated blood loss of >15% of blood volume, or an expected transfusion requirement of at least two packed red blood cells with general or combined anaesthesia.
- Patients with American Society of Anesthesiologists (ASA) status III or IV.
- Written informed consent.
Who cannot join
- Patients under 18 years
- Lack of health insurance
- Pregnancy
- Known history of congenital heart disease, severe aortic and/or mitral stenosis, heart failure and ejection fraction < 35 %
- Persistent atrial fibrillation and other arrhythmias impairing arterial pressure cardiac output monitoring
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Intensive Therapy and Pain Management
Poznan, Poznań, 60-355
Jakub Szrama, PhD, +48618691856, jakub.szrama@gmail.com
Agata Gradys, PhD, +48618691856, agatagradys@gmail.com
About this study
Official title: The Hypotension Prediction Index in Major Abdominal Surgery - a Prospective Randomized Clinical Trial.
The goal of this randomized clinical trial is to compare different types of advanced hemodynamic monitoring in patients undergoing major abdominal surgery.
Participants undergoing major abdominal surgery will receive anesthesia with two different types of hemodynamic monitoring - group A will receive arterial pressure cardiac output algorithm with the FloTrac sensor and group B will receive hemodynamic monitoring with the Hypotension Prediction Index.
The main question the study aims to answer is:
- will the hypotension prediction index algorithm reduce the rate of hypotension in comparison to arterial pressure cardiac output algorithm.
Read the detailed description
The fundamental aspect of the anesthetics perioperative management is to maintain hemodynamic stability, with special attention on the avoidance or reduction of the episodes of intraoperative hypotension (IOH). The incidence of intraoperative hypotension is related to an increased rate of perioperative morbidity and mortality. Even a short period of hypotension can be related to an increased risk of postoperative stroke, myocardial injury and acute kidney injury. Patients undergoing major abdominal surgery are at a high-risk of IOH because such surgeries typically require more than 2h to complete and require blood transfusion or inotrope administration. Hemodynamic monitoring and the use of goal directed therapy protocols helps to diminish the incidence of perioperative complications, however the hypotension management remains a reactive approach, an intervention is made when the hypotension has already occured. The Hypotension Prediction Index is an machine learning algorithm which allows to predict the episodes of hypotension and intervene before mean arterial pressure drops below 65 mmHg. The aim of the current study is to compare the rate of hypotension in patients undergoing major abdominal surgery with the arterial pressure cardiac output algorithm and the hypotension prediction index algorithm.
- Conditions
- Hypotension During Surgery
- Being tested
- Hypotension Prediction Index Hemodynamic Monitoring
- Keywords
- hypotension prediction index, major abdominal surgery, arterial pressure cardiac output, intraoperative hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypotension Prediction Index Hemodynamic MonitoringDevice
The application of the perioperative hemodynamic management according to the hypotension prediction index algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Group A - FloTrac group | No intervention | Patients receiving standard therapy with the arterial pressure cardiac output hemodynamic monitoring |
| Group B - HPI - Hypotension Prediction Index group | Experimental | Patients receiving therapy according to the hypotension prediction index hemodynamic monitoring. Receives: Device: Hypotension Prediction Index Hemodynamic Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time weighed average of hypotension below 65 mmHg
depth of hypotension in millimetres of mercury below a mean arterial pressure (MAP) of 65 mmHg x time in minutes spent below MAP of 65mmHg)/total duration of operation in minutes
Measured: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
Secondary outcomes (10)
Time weighed average of hypotension below 50 mmHg
depth of hypotension in millimetres of mercury below a MAP of 50 mmHg x time in minutes spent below MAP of 50 mmHg)/total duration of operation in minutes
Measured: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
Time weighed average of hypertension above 90 mmHg
rise of hypertension in millimetres of mercury above a MAP of 90 mmHg x time in minutes spent above MAP of 90 mmHg)/total duration of operation in minutes
Measured: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
Time weighed average of hypertension above 100 mmHg
rise of hypertension in millimetres of mercury above MAP of 100 mmHg x time in minutes spent above MAP of 100 mmHg)/total duration of operation in minutes
Measured: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
30 day mortality
30 day mortality
Measured: 30 consecutive days starting from the day of the surgery
Length of hospitalisation
Length of hospitalisation
Measured: From the date of randomisation to the date of hospital discharge or death, whichever comes first, assessed up to 30 days
Myocardial injury evaluated by postoperative troponin levels
Myocardial injury evaluated by postoperative troponin levels
Measured: First, second and fifth postoperative day
Kidney injury evaluated by creatinine levels
Kidney injury evaluated by creatinine levels (increase in sCr by ≥0.3 mg/dL within 48 hours; increase in sCr to 1.5 times baseline; or urine volume less than 0.5 mL/kg/h for 6 hours)
Measured: First, second and fifth postoperative day
Intraoperative fluid dose
Intraoperative fluid administration
Measured: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
Intraoperative vasopressor dose
Intraoperative vasopressor dose
Measured: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
Rate of intra and postoperative atrial fibrillation
the occurrence of atrial fibrillation in the intraoperative and postoperative period up to 30 days
Measured: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypotension During SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jakub Szrama
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jakub Szrama, Poznan University of Medical Sciences
- Investigators
- Krzysztof Kusza, Prof., Study chair, Poznan Univeristy of Medical Sciences, Department of Anesthesiology, Intensive Therapy and Pain Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247384
- Sponsor's protocol ID
- PoznanUMSHPI
- Status last verified
- Jul 2025
- First submitted
- 9 Jan 2024
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Szrama J, Gradys A, Nowak Z, Lohani A, Zwolinski K, Bartkowiak T, Wozniak A, Koszel T, Kusza K. The hypotension prediction index in major abdominal surgery - A prospective randomised clinical trial protocol. Contemp Clin Trials Commun. 2024 Dec 28;43:101417. doi: 10.1016/j.conctc.2024.101417. eCollection 2025 Feb.
PubMed 39895857
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hypotension Prediction Index in Major Abdominal Surgery - a Prospective Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06247384
- Acronym / sponsor ID
- PoznanUMSHPI
- Conditions
- Hypotension During Surgery
- Keywords
- hypotension prediction index, major abdominal surgery, arterial pressure cardiac output, intraoperative hypotension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Jakub SzramaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized clinical trial is to compare different types of advanced hemodynamic monitoring in patients undergoing major abdominal surgery.
Participants undergoing major abdominal surgery will receive anesthesia with two different types of hemodynamic monitoring - group A will receive arterial pressure cardiac output algorithm with the FloTrac sensor and group B will receive hemodynamic monitoring with the Hypotension Prediction Index.
The main question the study aims to answer is:
- will the hypotension prediction index algorithm reduce the rate of hypotension in comparison to arterial pressure cardiac output algorithm.
Detailed description
The fundamental aspect of the anesthetics perioperative management is to maintain hemodynamic stability, with special attention on the avoidance or reduction of the episodes of intraoperative hypotension (IOH). The incidence of intraoperative hypotension is related to an increased rate of perioperative morbidity and mortality. Even a short period of hypotension can be related to an increased risk of postoperative stroke, myocardial injury and acute kidney injury. Patients undergoing major abdominal surgery are at a high-risk of IOH because such surgeries typically require more than 2h to complete and require blood transfusion or inotrope administration. Hemodynamic monitoring and the use of goal directed therapy protocols helps to diminish the incidence of perioperative complications, however the hypotension management remains a reactive approach, an intervention is made when the hypotension has already occured. The Hypotension Prediction Index is an machine learning algorithm which allows to predict the episodes of hypotension and intervene before mean arterial pressure drops below 65 mmHg. The aim of the current study is to compare the rate of hypotension in patients undergoing major abdominal surgery with the arterial pressure cardiac output algorithm and the hypotension prediction index algorithm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - FloTrac group | No intervention | –Patients receiving standard therapy with the arterial pressure cardiac output hemodynamic monitoring |
| Group B - HPI - Hypotension Prediction Index group | Experimental | Device: Hypotension Prediction Index Hemodynamic MonitoringPatients receiving therapy according to the hypotension prediction index hemodynamic monitoring. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients qualified for elective major abdominal surgery, defined as an expected duration of more than two hours, an estimated blood loss of >15% of blood volume, or an expected transfusion requirement of at least two packed red blood cells with general or combined anaesthesia.
- Patients with American Society of Anesthesiologists (ASA) status III or IV.
- Written informed consent.
Key exclusion criteria (5 listed)
- Patients under 18 years
- Lack of health insurance
- Pregnancy
- Known history of congenital heart disease, severe aortic and/or mitral stenosis, heart failure and ejection fraction < 35 %
- Persistent atrial fibrillation and other arrhythmias impairing arterial pressure cardiac output monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypotension Prediction Index Hemodynamic MonitoringThe application of the perioperative hemodynamic management according to the hypotension prediction index algorithm. | Device | Group B - HPI - Hypotension Prediction Index group |
Primary outcome
Time weighed average of hypotension below 65 mmHg
Time frame: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
depth of hypotension in millimetres of mercury below a mean arterial pressure (MAP) of 65 mmHg x time in minutes spent below MAP of 65mmHg)/total duration of operation in minutes
10 secondary outcomes
Time weighed average of hypotension below 50 mmHg
Time frame: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
Time weighed average of hypertension above 90 mmHg
Time frame: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
Time weighed average of hypertension above 100 mmHg
Time frame: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
30 day mortality
Time frame: 30 consecutive days starting from the day of the surgery
Length of hospitalisation
Time frame: From the date of randomisation to the date of hospital discharge or death, whichever comes first, assessed up to 30 days
Myocardial injury evaluated by postoperative troponin levels
Time frame: First, second and fifth postoperative day
Kidney injury evaluated by creatinine levels
Time frame: First, second and fifth postoperative day
Intraoperative fluid dose
Time frame: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
Intraoperative vasopressor dose
Time frame: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
Rate of intra and postoperative atrial fibrillation
Time frame: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Derived from this study: PubMed 39895857Szrama J, Gradys A, Nowak Z, Lohani A, Zwolinski K, Bartkowiak T, Wozniak A, Koszel T, Kusza K. The hypotension prediction index in major abdominal surgery - A prospective randomised clinical trial protocol. Contemp Clin Trials Commun. 2024 Dec 28;43:101417. doi: 10.1016/j.conctc.2024.101417. eCollection 2025 Feb.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Krzysztof Kusza, Prof. study chair
Poznan Univeristy of Medical Sciences, Department of Anesthesiology, Intensive Therapy and Pain Management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypotension Prediction Index Hemodynamic Monitoring in people with Hypotension During Surgery, run by Jakub Szrama at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakub Szrama, Ph.D. (+48602170037, jakub.szrama@usk.poznan.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time weighed average of hypotension below 65 mmHg (time frame: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06247384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.